BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇳 China

    Medical Diode Laser Systems (VELAS II-30B, VELAS II-30A, GBOX-15AB, GBOX-20B, CHEESE II-10B)

    K Number: K242755 · Decision May 19, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    423
    Registration Numbers
    423
    Same Product Code
    227
    Applicant Total
    4
    Review Days
    249

    Basic Information

    Device Name
    Medical Diode Laser Systems (VELAS II-30B, VELAS II-30A, GBOX-15AB, GBOX-20B, CHEESE II-10B)
    K Number
    K242755
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.5500
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Gigaalaser Company Ltd.
    Date Received
    September 12, 2024
    Decision Date
    May 19, 2025
    Product Code
    ILY
    Advisory Committee
    Physical Medicine
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    ILY Lamp, Infrared, Therapeutic Heating

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    Other Clearances by Gigaalaser Company Ltd.

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